Unlicensed and Off-Label Medicines

At MyHairImplants, our clinicians may sometimes prescribe treatments that are described as “off-label” or “unlicensed.” This page explains what these terms mean and why such treatments may be used as part of your care.

Understanding medicine licensing

In the UK, most medicines receive a marketing authorisation (also known as a product licence) before they are widely supplied. This approval confirms that regulators have reviewed the medicine’s quality, safety and effectiveness for specific conditions, doses and methods of use.

The licence outlines details such as:

the condition the medicine is approved to treat

the recommended dosage

how the medicine should be taken

which groups of patients it is suitable for

When a medicine is used exactly according to these approved conditions, it is known as licensed or “on-label” use.

What is off-label use?

A medicine is considered off-label when it is prescribed in a way that differs from the exact terms of its licence. This may include:

using the medicine to treat a different condition

prescribing a different dose

using a different formulation or method of administration

Even if a medicine is not licensed for a particular use, healthcare professionals may still prescribe it when clinical evidence or established medical practice supports its safety and effectiveness. Off-label prescribing is common across many areas of medicine and is a recognised part of clinical practice.

What does “unlicensed medicine” mean?

An unlicensed medicine is a treatment that does not currently hold a UK product licence.

This may happen for several reasons, for example:

the medicine is still awaiting regulatory approval

the treatment is licensed in another country but not in the UK

the medicine has been specially prepared for a specific patient

the manufacturer has not applied for a licence for that particular product

In some cases, medicines may be produced by a licensed manufacturer when there is no suitable licensed alternative available.

Why these medicines may be prescribed

Healthcare professionals may prescribe off-label or unlicensed treatments when they believe doing so is in the patient’s best medical interests.

This may be considered when:

research or clinical experience suggests the treatment may be beneficial

licensed treatments have not produced the desired results

a different formulation better suits the patient’s needs

there is no licensed treatment available for the condition

Regulatory guidance states that prescribers must be satisfied that there is sufficient evidence or experience supporting the medicine’s safety and effectiveness before recommending it.

How this applies to hair-loss treatments

Hair-loss treatment is one area where medicines are sometimes used outside their original licence conditions.

This does not mean the treatment is unsafe or experimental. In many cases:

the medicine has been used in clinical practice for many years

research supports its use for hair loss

healthcare professionals have significant experience prescribing it

Your clinician will only recommend a treatment after reviewing your consultation and determining whether it is appropriate for you.

Safety and clinical oversight

When prescribing treatments, clinicians at MyHairImplants follow established medical standards.

This includes:

reviewing your consultation and medical history

assessing whether the treatment is suitable for you

prescribing only when the potential benefits outweigh the risks

providing guidance on how to use the medication safely

If you have any questions about your treatment or how it works, our clinical team will be happy to help.